Engineering Technical Specialist

Vector BioMed, Inc.; Gaithersburg (MD); On-site; USD 85,000 - 115,000; Full time

Job summary

Vector BioMed, Inc. seeks an Engineering Technical Specialist to provide direct and indirect technical support for GMP and Non-GMP operations across process development, clinical, and manufacturing.

The role covers validation, metrology, and facilities maintenance for equipment and systems to ensure quality and reliability. You will develop validation documentation (IORQ/IOPQ), execute protocols, address deviations, and prepare final reports.

Qualifications

• Bachelor’s degree in science or related discipline preferred but professional experience may substitute.
• 3+ years of recent experience in metrology, facilities maintenance, or Electronic Maintenance System.
• Good understanding of cGMPs, regulatory requirements, and quality systems.
• Strong written and verbal communication.
• Proficient in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).

Responsibilities

• Develop, validate, and document protocols including IOPQ.
• Execute protocols, address deviations, and finalize reports.
• Coordinate scheduling with stakeholders and ensure documentation closure.
• Review and approve validation documents and calibration reports.
• Oversee vendor qualification and service work orders where applicable.
• Respond to building/equipment alarms and perform simple calibrations as needed.
• Develop and manage work orders (corrective and preventive).
• Maintain eQMS lifecycle and onboard/offboard equipment/systems.

Skills

Metrology

Facilities maintenance

Electronic Maintenance System

Education

Bachelor's degree in science

Tools

Microsoft 365

Job description

Summary

The Engineering Technical Specialist will provide direct/indirect technical support for GMP and Non-GMP operations (Process Development, Clinical, and Manufacturing operations). The role encompasses validation, metrology and facilities maintenance for various equipment/systems. The candidate performs quality functions to ensure that equipment/systems and quality procedures adhere to system requirements and can perform properly and consistently.

Key Responsibilities

• Develop documentation related to validation/re-validation. These include but are not limited to User Requirements, Risk Assessments, Installation, Operation and Performance protocol (IOPQ)
• Execute protocols, address deviations/non-conformance, and develop final reports for executed protocols.
• Coordinate with key stakeholders on scheduling logistics, execution and documentation closure.
• Review/approve protocols, reports and validation summary packages
• Where applicable, manage and provide oversight on vendor qualification support.
• Coordinate with system owners to ensure schedule adherence
• Review and approve calibration/certification reports
• Address relevant out-of-calibration and/or excursions
• Where applicable, perform simple calibration that includes but not limited to temperature, pressure and relative humidity.
• Develop, execute and address work orders (corrective and preventive)
• Provide oversight, review and approve vendor/contractor service work orders
• Respond to building/equipment alarms as needed

Electronic Quality Maintenance System (eQMS Maintenance) (25%)

• Provide technical support to develop and maintain equipment/system life cycle.
• Work cross-functionally to onboard and offboard equipment/systems
• Assess and evaluate opportunities to enhance equipment/system life cycle.

Basic Qualifications

• Education: Bachelor’s degree in science or relevant discipline preferred but professional experience in appropriate role may substitute.
• Experience: 3+ years of recent experience in one or more of the following areas:
  • Metrology
  • Facilities maintenance
  • Electronic Maintenance System
• Good understanding cGMP’s, regulatory requirements, and quality systems.
• Strong written and verbal communication
• Good troubleshooting, problem-solving skills and attention to detail.
• Sound knowledge in Microsoft 365 (Word, Excel, PowerPoint, Teams, SharePoint, OneDrive).

Salary Range: $85k - 115k per year

Physical Requirements

• Ability to move 50 lbs.
• Ability to climb ladders and stairs
• Must be able to perform repetitive motion activities during working hours
• Occasional off-hours and weekends as needed.
• Ability to use basic tools with proficiency